Land: Nederland
Taal: Nederlands
Bron: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
OXYCODONHYDROCHLORIDE SAMENSTELLING overeenkomend met ; OXYCODON
Centrafarm B.V. Nieuwe Donk 3 4879 AC ETTEN LEUR
N02AA05
OXYCODONHYDROCHLORIDE COMPOSITION corresponding to ; OXYCODONE
Capsule, hard
AMMONIA (E 527) ; CELLULOSE, MICROKRISTALLIJN (E 460) ; GELATINE (E 441) ; IJZEROXIDE GEEL (E 172) ; IJZEROXIDE ROOD (E 172) ; IJZEROXIDE ZWART (E 172) ; INDIGOKARMIJN (E 132) ; KALIUMHYDROXIDE (E 525) ; MAGNESIUMSTEARAAT (E 470b) ; NATRIUMLAURILSULFAAT (E 487) ; PROPYLEENGLYCOL (E 1520) ; SCHELLAK (E 904) ; TITAANDIOXIDE (E 171) ; ZWARTE INKT,
Oraal gebruik
Oxycodone
Hulpstoffen: AMMONIA (E 527); CELLULOSE, MICROKRISTALLIJN (E 460); GELATINE (E 441); IJZEROXIDE GEEL (E 172); IJZEROXIDE ROOD (E 172); IJZEROXIDE ZWART (E 172); INDIGOKARMIJN (E 132); KALIUMHYDROXIDE (E 525); MAGNESIUMSTEARAAT (E 470b); NATRIUMLAURILSULFAAT (E 487); PROPYLEENGLYCOL (E 1520); SCHELLAK (E 904); TITAANDIOXIDE (E 171); ZWARTE INKT;
2017-11-03
1 PACKAGE LEAFLET: INFORMATION FOR THE USER OXYCODON HCL CF 5 MG, HARDE CAPSULES OXYCODON HCL CF 10 MG, HARDE CAPSULES OXYDOCON HCL CF 20 MG, HARDE CAPSULES For adults and adolescents over 12 years of age. Oxycodone hydrochloride READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor or pharmacist. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What [Product name] is and what it is used for 2. What you need to know before you take [Product name] 3. How to take [Product name] 4. Possible side effects 5. How to store [Product name] 6. Contents of the pack and other information 1. WHAT [PRODUCT NAME] IS AND WHAT IT IS USED FOR [Product name] is a centrally acting, strong painkiller from the group of opioids. [Product name] is used to treat severe pain, which can only be adequately managed with opioid analgesics. For adults and adolescents over 12 years of age. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE [PRODUCT NAME] DO NOT TAKE [PRODUCT NAME] if you are allergic to oxycodone hydrochloride or any of the other ingredients of this medicine (listed in section 6) if you suffer from severely depressed breathing (respiratory depression) with too little oxygen in the blood (hypoxia) and/or too much carbon dioxide (hypercapnia) in the blood if you suffer from severe chronic obstructive lung disease, cor pulmonale (cardiac changes due to chronic overload of lung circulation) or acute, severe bronchial asthma if you suffer from intestinal paralysis (paralytic ileus) if your doctor has told you not to take strong pain killer (opioid) WARNINGS AND PRECAUTIONS Talk Lees het volledige document
1 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Oxycodon HCl CF 5 mg, harde capsules Oxycodon HCl CF 10 mg, harde capsules Oxycodon HCl CF 20 mg, harde capsules 2. QUALITATIVE AND QUANTITATIVE COMPOSITION [Product name] 5 mg capsules: Each hard capsule contains 5 mg oxycodone hydrochloride corresponding to 4.5 mg oxycodone. [Product name] 10 mg capsules: Each hard capsule contains 10 mg oxycodone hydrochloride corresponding to 9 mg oxycodone. [Product name] 20 mg capsules: Each hard capsule contains 20 mg oxycodone hydrochloride corresponding to 18 mg oxycodone. Excipient(s) with known effect Each hard capsule contains up to 0.003 mg sodium. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Capsule, hard [Product name] 5 mg capsules: Hard capsules, size 4, 14.4 mm in length, with a dark pink body marked with ‘5’ and a brown cap marked with ‘OXY’. [Product name] 10 mg capsules: Hard capsules, size 4, 14.4 mm in length, with a white body marked with ‘10’ and a brown cap marked with ‘OXY’. [Product name] 20 mg capsules: Hard capsules, size 4, 14.4 mm in length, with a light pink body marked with ‘20’ and a brown cap marked with ‘OXY’. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Severe pain, which can only be adequately managed with opioid analgesics. For adults and adolescents over 12 years of age. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Some patients who receive a retarded oxycodone preparation according to a fixed schedule require fast-release analgesics as an on-demand medication for controlling breakthrough pain.can be used for the treatment of these breakthroughs. 2 Lees het volledige documentcapsules are available for dosage adjustment and for the treatment of breakthrough pain. Posology The dose depends on the intensity of pain and the patient’s individual susceptibility to the treatment. In general, the lowest effective analgesic dose should be chosen. The following general dose recommendations apply: Adults and adolescents